Clinical Trial: Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatmen
Brief Summary: All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.
Detailed Summary: This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.
Sponsor: Ulthera, Inc
Current Primary Outcome: Improvement in overall lifting and tightening of the skin [ Time Frame: 90 days post-treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Overall aesthetic improvement [ Time Frame: 365 days post-treatment ]
Original Secondary Outcome: Same as current
Information By: Ulthera, Inc
Dates:
Date Received: October 15, 2012
Date Started: April 2012
Date Completion:
Last Updated: September 9, 2013
Last Verified: September 2013